What is levosimendan used for?

Levosimendan (Simdax) is used in the short-term treatment of acutely decompensated severe chronic heart failure when conventional therapy is not sufficient, and in cases where inotropic support is considered appropriate. It helps to improve the symptoms of shortness of breath and fatigue in heart failure. It is approved in roughly 60 countries worldwide, but it not yet approved in the U.S.

Positive inotropic support helps the heart muscle to beat or contract with more power. This helps to get more blood to organs so they can get the oxygen they need.

Levosimendan is classified as a vasodilator and cardiac stimulant and is given as an intravenous infusion. An oral formulation for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) is expected to undergo Phase III research in the U.S. by Tenax Therapeutics.

Is levosimendan approved in the U.S?

Levosimendan is not approved by the U.S. Food and Drug Administration (FDA) for any use.

In the U.S. it is currently under Phase III development by Tenax Therapeutics (TNX-103) as an oral agent to treat Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF).

In the HELP (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) Phase 2 study, researchers evaluated the effects of intravenous (IV) levosimendan at rest, during exercise, and on exercise capacity after 6 weeks of treatment in patients with advanced PH-HFpEF.

• Initially, the Phase 2 study included a heart catheterization at rest and exercise before and after receiving levosimendan for 24 hours. Results showed a marked effect in lowering the pulmonary capillary wedge pressure (PCWP) and the central venous pressure.
• The next phase involved a randomized placebo-controlled design to assess longer-term effects over a 6-week period, as well as improvement in exercise capacity as determined by a 6 minute walk test.
• After 6 weeks, levosimendan led to sustained hemodynamic effects and an improvement in exercise capacity when compared to the placebo group, which had no change in hemodynamics and worsened exercise capacity.

According to the sponsor, oral levosimendan (not the IV form) is anticipated to undergo Phase 3 research compared to the IV form in patients with PH-HFpEF in anticipation of submission to the FDA for regulatory approval.

Researchers are conducting an IV to oral transition study in the patients who have been receiving weekly IV infusions in the Phase 2 HELP Study extension to determine the optimal dosing regimen for the Phase 3 study.

The sponsor stated "To date, no other drug therapy has improved exercise tolerance in patients with PH associated with HFpEF, recently referred to as the greatest unmet need in cardiovascular disease."

Tenax Therapeutics can be reached at 101 Glen Lennox Drive, Suite 300, Chapel Hill, NC 27517. Phone: +1-919.855.2100. Tenax Therapeutics has North American rights to develop and commercialize oral (TNX-103) and subcutaneous (TNX-102) formulations of levosimendan.

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What is the mechanism of action of levosimendan?

Levosimendan is classified as an inodilator (a calcium sensitizer and potassium
channel opener). It has a triple mechanism of action.

• It increases cardiac contractility by calcium sensitization of troponin C. This allows the heart to be stronger.
• It causes vessels to dilate through the opening of ATP-sensitive potassium channels in the heart vascular smooth muscle cells, which decreases the workload on the heart.
• It offers cardioprotection effects through the opening of mitochondrial potassium channels in heart cells responsible for contraction (heart beats).

What is the brand name for levosimendan?

Worldwide the most common brand or trade name for levosimendan is Simdax.

The Simdax brand may be found in several countries, including: Argentina, Austria, Peru, Uruguay, Mexico, New Zealand, Brazil, Turkey, Slovenia, Cyprus, Croatia, Bulgaria, Czech Republic, Estonia, Israel, France, Spain, Georgia, Greece, Hungary, Norway, Poland, Romania, Serbia, Slovakia, Iceland, Belgium,; Denmark, Finland, Germany, Italy, Sweden, Switzerland, Singapore, Slovenia, and Mexico.

Other brand names for levosimendan include Daxim in Venezuela, Chile, and Columbia.

What are the foreign names for levosimendan?

Foreign names for levosimendan include: levosimendanum (Latin), levosimendan (German), lévosimendan (French) and levosimendan (Spanish).

Foreign generic names for levosimendan include: lévosimendan.

Foreign manufacturers or distributors for levosimendan may include: Abbott, Richet, AbbVie, Aspen, Biolab Sanus Farmacêutica, Daiichi Sankyo, Kemofarmacija, Lifepharma, Medis Adria, Sakus, and Orion.

Who makes levosimendan?

Orion (Orion Pharma) is the most common manufacturer worldwide.

Levosimendan is marketed worldwide under the brand name Simdax by Orion Pharma, Finland (or their partners). They can be contacted at: Orion Corporation, Orionintie 1A, 02200 Espoo, PO Box 65, FI-02101 Espoo, Finland. Phone +358 104261.

Products may not always be reliable, safe or available in every foreign country listed. Some products may have been discontinued by foreign manufacturers, and this list may be incomplete. Use extreme caution if you are purchasing any medicine over the Internet, either domestic or international.

This is not all the information you need to know about levosimendan for safe and effective use and does not take the place of your doctor’s directions. Review the full product information from the country of origin and discuss its use with your health care provider before you use it. This information should not be used to decide whether or not to take this product.

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